Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics and safety of abt-493 and abt-530 in subjects with normal and impaired renal function

Conditions: Renal Impairment

Summary: this is an open-label, single dose study designed to assess the pharmacokinetics and safety of abt-493 and abt-530 in subjects with either normal renal function or impaired renal function.

up to 48 subjects will be selected and enrolled according to the subject selection criteria: 8 subjects with mild renal impairment (group 1), 8 subjects with moderate renal impairment (group 2), 8 subjects with severe renal impairment (group 3), 8 subjects with end stage renal disease that are not yet on dialysis (group 4), 8 healthy subjects with normal renal function (group 5), and 8 subjects with end stage renal disease on hemodialysis (group 6).

Eligibility criteria:
inclusion criteria: all subjects * females must have negative results for pregnancy tests performed: * at screening on a urine specimen, and * on a serum sample obtained on study day -2 (prior to dosing). * body mass index (bmi) is ≥ 18 to ≤ 38 kg/m2, inclusive. * body weight \> 50 kg. subjects with normal renal function in addition to the main inclusion criteria above for all subjects, the following criteria must be met for subjects with normal renal function enrolled in group 5: * judged to be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ecg). * at screening, estimated gfr (by mdrd equation) should be ≥ 90 ml/min/1.73 m2. subject with renal impairment in addition to the main inclusion criteria for all subjects, the following criteria must be met for all subjects with renal impairment enrolled in groups 1, 2, 3, 4 and 6: * judged to be in stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile and ecg. * presence of chronic renal impairment as indicated by medical history and a screening estimated gfr (by mdrd equation) \< 90 ml/min/1.73 m2. * subjects with esrd undergoing hemodialysis should have been receiving dialysis for at least 1 month. exclusion criteria: - history of significant sensitivity to any drug. * pregnant or breastfeeding female. * recent (6-month) history of drug or alcohol abuse. * positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag) or hepatitis c virus antibody (hcv ab) or hiv antibodies (hiv ab). negative hiv status will be confirmed at screening and the results will be maintained confidentially by the study site. * subjects on strict vegetarian diet.

Keywords: renal impairment
the safety ,tolerability and efficacy study of hepacure in chinese subjects with acute-on-chronic liver failure

Conditions: Acute on Chronic Hepatic Failure; Liver Failure; Hepatitis

Summary: this is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in china to evaluate the efficacy, safety and tolerability of hihep cell-based bio-artificial liver support system (hepacure) plus dpmas versus dpmas alone in chinese subjects with acute-on-chronic liver failure（aclf）. phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of hepacure with different treatment duration plus dpmas in aclf subjects respectively. phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of hepacure plus dpmas and lpe in aclf subjects


Eligibility criteria:
inclusion criteria: 1. able to communicate effectively with investigators and sign the informed consent form (icf) voluntarily. 2. age: ≥ 18 years and ≤ 65 years. 3. body weight: ≥ 40kg; 4. met the criteria of aclf in the early and middle stages in screening period (guidelines for the diagnosis and treatment of liverfilture (2018 edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; progressive deepening of jaundice, serum tbil ≥ 171 μmol/l or increase ≥ 17.1 μmol/l daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%\<pta ≤ 40% (or 1.5 ≤ inr\<2.6), and other reasons excluded. exclusion criteria: 1. subjects with primary or metastatic liver cancer. 2. subjects with severe esophageal/gastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results. 3. serum creatinine was greater than 132.6 μmol/l. 4. subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the american society of infectious diseases/american thoracic society for adult severe pneumonia in 2007), abdominal infection (exist peritonitis manifestations or white blood cells in ascites\>0.1 × 10 9/l after reasonable antibiotic treatment), etc;
hiv vaccine designed for hiv infected adults taking anti-hiv drugs

Conditions: HIV Infections

Summary: this study will evaluate the safety of and immune responses to a dendritic cell vaccination for hiv-1 infection. the vaccine will be made from a patient's own cells combined with small fragments of hiv-1 (made synthetically in a laboratory). these cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).

untreated hiv-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and aids-associated malignancies. highly active antiretroviral therapy (haart) has been successful in suppressing hiv replication and restoring partial immune function. however, hiv-specific immunity remains poor, as evidenced by rapid rebound of hiv-1 rna following haart withdrawal. studies of individuals with acute hiv-1 infection, as well as those who are long-term nonprogressors, have suggested that robust hiv-specific immune responses are associated with control of hiv-1 viremia. dendritic cells (dcs) are potent antigen presenting cells that may increase hiv-specific immune responses. this protocol will evaluate the use of dcs to help control hiv infection. patients will be randomized to receive either intravenous or subcutaneous administration of hiv antigen expressing dcs. each subject will receive two administrations of mature dcs given 3 weeks apart. subjects will be followed weekly for 8 weeks, then at weeks 12, 16, 24, 36, and 48. two doses of dcs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.

Eligibility criteria:
inclusion criteria * hiv-1 infection * current cd4 count more than 400/mm3 * hiv rna less than 400 copies/ml * stable combination antiretroviral therapy for at least 4 weeks prior to study entry * hla a2.1 (to be tested at screening) exclusion criteria * prior hiv vaccine * systemic steroids or immunosuppressive drugs within 30 days of study entry * pregnant or breastfeeding

Keywords: hiv-1 haart therapeutic immunization hiv therapeutic vaccine treatment experienced
"bio-logical" carbon fiber intramedullary nail biomechanical test and preliminary clinical results

Conditions: Fractures, Bone

Summary: the aim of this study is to present a novel intramedullary nail (imn) made of cfr - peed composite, that is biomechanically tailored to closely match cortical bone. this imn should promote fracture healing and prevent stress shielding osteopenia. case records of patients with humurus shaft fracture will be retrospectively reviewed to determine whether the implant promotes bone healing.


Eligibility criteria:
inclusion criteria: * broken humerus shaft exclusion criteria: * all others
the effects of an acute high-intensity exercise on heart and brain function in people with spinal cord injury

Conditions: Autonomic Nervous System Disease; Spinal Cord Injuries; Cognition

Summary: the heart and brain are regulated by the autonomic nervous system. control of these organs can be disrupted in people with spinal cord injury (sci). this may affect their ability to regulate blood pressure during daily activities and process the high-level information. previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. however, it is unknown the effects of high-intensity exercise on heart and brain function in people with sci. therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with sci compared to age- and sex-matched non-injured controls.

this study will be a cohort control study involving two groups: individuals with sci, whose level of injury is at the 6th thoracic vertebra or above, and age- and sex-matched controls. eligible participants will be asked to visit the laboratory located at 115 kimball tower, university at buffalo south campus, twice. the first visit takes up to 3 hours, and the second visit takes up to 5 hours.

Eligibility criteria:
inclusion criteria: 1. diagnosed with a traumatic or non-traumatic spinal cord injury and have ≥4/5 strength in at least one cervical 5 myotome (elbow flexors), allowing to utilize the arm ergometer and level of injury at or above the 6th thoracic vertebra 2. classified as a, b, c, d (motor and sensory complete or incomplete) on the american spinal injury association (asia) impairment scale (ais) 3. longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment 4. english is the first language 5. at least one of the cerebral arteries (i.e., middle cerebral artery and/or posterior cerebral artery) can be found via transcranial doppler exclusion criteria: 1. medical conditions that preclude exercise, such as unstable angina, uncontrolled arrhythmias, a recent history of congestive heart failure that has not been evaluated and effectively treated, severe valvular disease, uncontrolled hypertension (i.e., resting systolic blood pressure ≥ 160 mmhg and/or diastolic blood pressure ≥ 105 mmhg) 2. moderate-severe traumatic brain injury 3. diabetes 4. color blindness 5. pre-existing shoulder injuries 6. pregnancy
motivational interviewing on healthy lifestyle behaviors and quality of life in on menopausal women

Conditions: Menopause; Nursing

Summary: background: this study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women. methods: this is a randomized controlled empirical study. the study was conducted with a total of 136 women, including 68 for experimental group and 68 for control group. the data were collected using an introductory information form, the health promoting lifestyle profile ii (hplpl ii) and the menopause-specific quality of life (menqol). women in the experimental group received 6 sessions of motivational interviewing and 2 follow-up interviews in two family health centers (fhcs) from the researcher. no intervention was applied to women in the control group. the data were analyzed using number, percentage, mean, standard deviation, chi-square test, bonferroni test, independent samples t test and repeated anova.


Eligibility criteria:
inclusion criteria: 1. being literate; 2. being able to make a conscious decision to participate in the study, being able to communicate verbally, and being able to sign a consent form; 3. having had menopause naturally and within the last 3 years; 4. being sexually active; 5. having no hormone replacement therapy. exclusion criteria: 1. unwilling to continue the study; 2. having a psychiatric diagnosis according to the fhc records.

Keywords: motivational interviewing healthy lifestyle behavior menopause specific quality of life
evaluation of the effects of smoking on trabecular bone microarchitecture using cbct in periodontal disease

Conditions: Cone Beam Computed Tomography; Periodontitis; Diagnosis of Bone Quality; Diagnosis, Oral; Smoking, Cigarette

Summary: the purpose of this cross-sectional study is to evaluate the morphometric properties of trabecular bone quality using cone-beam computed tomography in periodontal disease at different stages, comparing smokers and non-smokers.

this cross-sectional study aimed to analyze changes in trabecular bone quality associated with smoking inindividuals with periodontal disease using morphometric analysis of cone beam computed tomography (cbct)images. materials-methods: the study involved 90 systemically healthy patients who were smokers (\>=10cigarettes/day) or non-smokers, and were indicated for cbct.clinical periodontal parameters (plaque index, gingival index, probing pocket depth, bleeding on probing, clinicalattachment loss (cal)) were recorded. participants were divided into two main groups based on smoking statusand three subgroups based on periodontal diagnosis: gingivitis, stage i-ii periodontitis, and stage iii-ivperiodontitis (n=15). mandibular first molars and central incisors without prosthetic restorations, endodonticlesions, or root canal treatments were included. two volumetric regions of interest (rois) with dimensions of5x5x10 mm were selected around the apices of these teeth: posterior roi and anterior roi. trabecular bonemicro-architecture was analyzed using the bonej plugin for morphometric parameters: anisotropy (da), bonevolume fraction (bv/tv), trabecular thickness (tb.th), and trabecular separation (tb.sp). statistical analysis wasperformed using student's t-test, one-way anova, and kruskal-wallis tests.

Eligibility criteria:
inclusion criteria: * individuals aged 18 years or older who are systemically healthy. * presence of mandibular molars and mandibular anterior teeth. * no pathologies affecting the alveolar bone. * no history of orthodontic treatment. * no use of medication that may impact bone health. * no history of radiation or chemotherapy treatment. * selected mandibular molars and central incisors must be free of caries. selected teeth must not have crowns, root canal treatments, or endodontic lesions. exclusion criteria: * patients who are exhibiting signs of occlusal trauma * patients who are bruxism

Keywords: cone beam computed tomography periodontitis diagnosis
multicenter real-world cohort study evaluating the impact of early intensive lipid-lowering therapy on the prognosis of acute coronary syndrome patients(elite-acs)

Conditions: Acute Coronary Syndromes

Summary: the purpose of this clinical trial is to evaluate the impact of early initiation of pcsk9 inhibitor therapy for intensive lipid-lowering in chinese patients with acute coronary syndrome (acs) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events. the primary research question is whether early initiation of pcsk9 inhibitor therapy during hospitalization for acs patients in a real-world chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events. researchers will compare three lipid-lowering strategies: pcsk9 inhibitor therapy (with or without statins ± ezetimibe/hybutimibe), statin plus ezetimibe/hybutimibe therapy, and statin monotherapy, to assess the potential of pcsk9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in acs patients. participants will: receive pcsk9 inhibitor therapy (with or without daily statins ± ezetimibe/hybutimibe) every two weeks, or daily statin plus ezetimibe/hybutimibe therapy, or daily statin monotherapy. undergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge. record the occurrence of major adverse cardiovascular events.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. this hospitalization for acs, which includes st-segment elevation mi (stemi), non-st-segment elevation mi (nstemi), or unstable angina pectoris (ua) with a grace score of intermediate to high risk. 3. written informed consent must be obtained from eligible patients prior to study enrollment. 4. ldl-c ≥1.8 mmol/l in patients using statin; ldl-c ≥2.6 mmol/l in those not taking statin in the last 4 weeks. exclusion criteria: 1. received pcsk9 inhibitor therapy within 3 months. 2. patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure. 3. patient has a history of renal or cardiac transplantation. 4. the patient is a pregnant or breastfeeding woman or a woman planning to become pregnant. patients judged by the investigator to be unsuitable for enrollment.

Keywords: acute coronary syndromes pcsk9 inhibitor lipid compliance time and rate first cardiovascular event
the safety and pharmacokinetics of intraperitoneal administration in patients undergoing appendectomy for uncomplicated appendicitis

Conditions: Appendicitis

Summary: the objective of this trial is to evaluate the safety of the intraperitoneal administration of the combination of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor (gm-csf) in patients undergoing surgery for uncomplicated appendicitis. further, in a sub-trial the aim is to investigate the plasma concentrations of fosfomycin and metronidazole after intraperitoneal administration.


Eligibility criteria:
inclusion criteria: * men ≥18 years old * suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual appendectomy * written informed consent after written and verbal information exclusion criteria: * cannot understand, read or speak danish * previous allergic reaction to fosfomycin, metronidazole, or gm-csf * perforated appendicitis (diagnosed either during surgery or at a preoperative computer tomography (ct) scan) * diagnostic laparoscopy revealing normal appendix not requiring an appendectomy * other intra-abdominal pathology requiring surgical intervention (diagnosed either during surgery or at a preoperative ct-scan) * known renal or hepatic disease or biochemical evidence at the time of admission * known autoimmune disease or other chronic inflammation * known hematologic disease or cancer * previous abdominal surgery (either laparoscopic or open surgery) * daily use or use of medication one week prior to or during the trial period apart from painkillers such as paracetamol, ibuprofen, tramadol, and morphine as well as drugs needed for anaesthesia, thrombosis prophylaxis, and nausea. limitations for antibiotics are defined below * use of other antimicrobial agents than the trial treatment one month before until 24 hours after the trial treatment * participant in another drug trial one month prior to the date of the surgery * body mass index ≥35 kg/m2 * weekly intake of alcohol \>14 units, where one unit corresponds to 12 g alcohol
preoperative anemia in the oncology population and associated mortality

Conditions: Anemia; Oncologic Surgery

Summary: anemia is a highly prevalent condition in the surgical population (1, 2). on the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). despite this, the prevalence of preoperative anemia in the chilean oncology population has not been quantified. to answer this question, a retrospective cohort study was designed between january and december 2022 to quantify the prevalence of anemia in the surgical population of the national cancer institute. in addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. statistical analysis will be performed using r. studio version 2023.09.1+494 (2023.09.1+494).

general objective: to quantify the prevalence of preoperative anemia in the national cancer institute's oncology surgical population and its impact on postoperative outcomes. specific objectives: 1. to quantify the prevalence of preoperative anemia in the national cancer institute's oncology population. 2. to stratify the prevalence of preoperative anemia in the national cancer institute's oncology population by severity. 3. to assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the national cancer institute's oncology population.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * oncologic surgery with curative intent exclusion criteria: * emergency surgery * patients who received a preoperative transfusion * patients without a preoperative blood count

Keywords: anemia oncologic surgery anesthesia
intracutaneous versus transcutaneous sutures in the face (ic vs tc sutures)

Conditions: Skin Tumour; Surgery

Summary: rationale: skin cancer is common in caucasians and often exists on sun-exposed areas, such as the face. treatment of choice is mostly excision and result in an irreversible scar. as the incidence of skin cancer is rising, also among young people, it is important to obtain a good cosmetic outcome after treatment. it is believed that the type of closure of the wound after excision can influence the cosmetic result. currently, primary closure of the excision can occur by transcutaneous (tc) or intracutaneous (ic) suturing. both techniques are widely used among dermatologists and plastic surgeons and the choice is mainly dependent on the preference of the physician. research comparing the cosmetic result of both techniques in the craniofacial area is lacking. objective: evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in the craniofacial area. study design: a randomized controlled single-blinded multi-center trial. study population: patients older than 18 years, with craniofacial skin tumor receiving surgery followed by primary closure at the department of dermatology and plastic surgery of the maastricht university medical centre, the department of dermatology of catharina hospital eindhoven and the department of plastic surgery of orbis medical centre sittard. intervention: excision of the tumor followed by ic sutures or tc sutures main study endpoints: cosmetic result measured on the patient and observer scar assessment scale (posas) by the patient and the researcher 12 months after surgery. nature and extent of the burden and risks associated with participation, benefit and group relatedness: all patients who participate have an indication for excision and will be assigned to one of the suture techniques. both techniques are widely used in the regular patient care. therefore, no extra risks are associated with it. patients will be asked to visit the hospital 3 months and 1 year following treatment, at which point a questionnaire will be filled in and the redness of the scar will be measured by means of non-invasive techniques. in addition, patients will be asked to apply a sunscreen on the scar daily during the first three months of follow-up.


Eligibility criteria:
inclusion criteria: * all patients aged 18 years or older with a skin tumour of minimal 5mm in diameter in the craniofacial area requiring an excision followed by primary closure will be included. if a patient has more than one lesion, the largest lesion that can be closed primarily will be included as a maximum of one tumour per patient will be studied. exclusion criteria: * patients with skin lesions on the ears, nose, mucosal part of the lips or eyelids as patients suited for excision but where a transplantation, flap or secondary granulation is necessary for reconstruction of the defect will be excluded. patients not capable of informed consent will also be excluded.

Keywords: intracutaneous sutures transcutaneous sutures dermatological surgery facial area